ATAR D-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10836559006210), received between Oct 5, 2018 and Oct 5, 2018 — classified as 1 malfunction.

2 other recalls cover devices cleared under the same FDA submission (K070926); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE HOSPITAL WAS HAVING ISSUES WITH OUR ATAR CABLES NOT STAYING CONNECTED TO THEIR TRANSVENOUS PACING LEADS AND MYOCARDIAL PACING WIRES. THEY ARE HAVING TROUBLE WITH LEADS PULLING OUT FROM THE DISTAL END OF THE ATAR CABLES AFTER THE RECEPTACLE CONNECTOR IS TIGHTENED DOWN. THEY STATED THAT IT HAS HAPPENED SEVERAL TIMES AND SOMETIMES IN EMERGENCY SITUATIONS WHERE THE NURSING STAFF HAVE GLOVES ON AND POSSIBLY BLOOD WHICH MAY AFFECT THEIR ABILITY TO TIGHTEN DOWN THE CONNECTOR. THEY SAID THEY HAVE HAD MULTIPLE ISSUES WHERE THEY LOST CAPTURE/PACING SEVERAL TIMES IN CRITICAL PATIENTS DUE TO CONNECTION ISSUES. THE REPORTER WAS NOT ABLE TO GET THE BRAND/MODELS OF THE TEMPORARY TRANSVENOUS PACING LEADS (CATH LAB) OR THE TEMPORARY PACING WIRES (CVOR) CURRENTLY USED BY THE HOSPITAL. PER THE HOSPITAL, THE DEVICE MODEL NUMBER IS ATAR D-A. ON 13-SEP-2018 ADDITIONAL INFORMATION WAS RECEIVED THE PATIENT HAD EXPIRED ON (B)(6) 2018. DURING CATH PROCEDURE PATIENT CODED. IT WAS RELATED TO PATIENT CONDITION; THE PACER HAD NOTHING TO DO WITH IT. THE HOSPITAL DOES NOT HAVE THE LOT NUMBER, AND THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THEY REPORTED THIS IS NOT A ONE-TIME INCIDENT. IT'S NO

  Patient problems: Death

  MAUDE report 7938460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070926. One submission often covers many models, so check the product and lot details in each record.

• Z-2733-2017 · Mar 31, 2017 · Terminated
  ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSAB
• Z-2340-2017 · Mar 31, 2017 · Terminated
  ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A